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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REVISION OPTICS RAINDROP NEAR VISION INLAY; CORNEAL INLAY

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REVISION OPTICS RAINDROP NEAR VISION INLAY; CORNEAL INLAY Back to Search Results
Model Number 610-0001
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Inflammation (1932)
Event Date 12/27/2017
Event Type  Injury  
Manufacturer Narrative
The explanted inlay was discarded by the facility and is not available for evaluation.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Inlay shifts in position, corneal inflammation, and epithelial ingrowth are listed in the device labeling as known potential risks.Complaint reference number: (b)(4).
 
Event Description
The patient underwent implantation of the raindrop corneal inlay in the left eye on (b)(6) 2017.Within the first 2 postoperative weeks the patient presented with inferior inlay decentration and inlay repositioning was planned.During this procedure inflammation was observed in the interface in the area of the inlay, likely due to a corneal abrasion a few days prior.In addition, epithelial ingrowth was observed near the corneal flap hinge.On (b)(6) 2017, the inlay was explanted and a replacement inlay will be implanted once the inflammation resolves and the eye is stable.Additional information has been requested.
 
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Brand Name
RAINDROP NEAR VISION INLAY
Type of Device
CORNEAL INLAY
Manufacturer (Section D)
REVISION OPTICS
25651 atlantic ocean dr.,
ste. a1
lake forest CA 92630 8835
Manufacturer (Section G)
REVISION OPTICS
25651 atlantic ocean dr.,
ste. a1
lake forest CA 92630 8835
Manufacturer Contact
pushpita singh
25651 atlantic ocean dr.,
ste. a1
lake forest, CA 92630-8835
9497072740
MDR Report Key7217652
MDR Text Key98164059
Report Number3005956347-2018-00017
Device Sequence Number1
Product Code LQE
UDI-Device Identifier10850394006013
UDI-Public(01)10850394006013
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150034
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 01/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date06/28/2020
Device Model Number610-0001
Device Catalogue NumberRD1-1
Device Lot Number003166
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/27/2017
Initial Date FDA Received01/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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